Effects of the Individual and Family Self-Management of Fall Prevention Program on Balance Ability and Fall Efficacy Among Chinese With Post-Stroke

Not Applicable

Not yet recruiting

• Conditions: Post-stroke People
• Interventions: Behavioral: individual and family self-management (IFSM) fall prevention program

• Registration Number: NCT06577662
• Lead Sponsor: Chiang Mai University

Brief Summary

This study is about exploring the effectiveness of individual and family self-management (IFSM) fall prevention programs on balance ability and fall efficacy in post-stroke people. The main intervention measures were developed based on the risk and protective factors of fall prevention in post-stroke people, including exercise, environment safety, assistant technology, medication review, and safety in daily activities. The intervention will be implemented in 10 weeks for both patients and their family members. By mastering these skills, post-stroke people may reduce the number of falls after discharge to home.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-08-27
• Last Update Submitted: 2024-08-27
• Study First Posted: 2024-08-29
• Last Update Posted: 2024-08-29
• Study Start: 2024-09-01
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• For patients (a) aged 18 years or above; (b) first-ever diagnosed with ischemic stroke; (c) level of impairment assessed by the National Institutes of Health Stroke Scale (NIHSS) scores between 5 to 15 (moderate severity) before entering the experiment; (d) mental state assessed by Mini-Mental State Exam score> 24; (e) mobility tested by Timed Up and Go ≥12.6 second (walkers or another kinds of gait aid are allowed to be used in the test); (f) motor power of all limbs examined by muscle power assessment grade ≥3; (g) ability to understand Chinese; (h) living with family members; (i) having phones that can use the internet; (j) willing to join the study.

For caregivers: (a) mental state assessed by a Short Portable Mental Status Questionnaire score≥8; (b) the primary caregiver who lives in the same house and takes care of the patients; (c) having phones that can use the internet; (d) willing to participate; and (e) can speak, understand, and write in Chinese

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Exclusion Criteria

• having problems with sensory and/or global aphasia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
individual and family self-management (IFSM) fall prevention program	individual and family self-management (IFSM) fall prevention program	The IFSM program lasts for ten weeks, two weeks in the hospital, and follow up at eight weeks after patients are discharged to home. It includes 11 sessions, including ten sessions developed in the inpatient department within two weeks and one online booster session developed in the first month (week 4) after discharge in home. There is also one session just for caregivers, which aims to improve caregivers' skills to keep patients' safety. In the process, self-efficacy strategies, self-regulation skills, and social facilitation will be used in every session. The main self-efficacy strategies include skill mastery, vicarious experience, and verbal persuasion. Several self-regulation skills for patients and caregivers are also used in the study, such as self-monitoring and reflective thinking. Additionally, two phone-visit will be provided for follow up after patients discharged from the hospital at week 2 and 4 (week 4 and 6 of the program) except the training.

Primary Outcome Measures

Name	Time	Method
Fall efficacy	Fall efficacy will be measured before the fall prevention program and after patients are discharged in 8 weeks.	Fall efficacy refers to the level of perceived confidence in undertaking everyday activities without falling, which includes self-efficacy in balance ability, preventing falls, and managing falls. Fall efficacy is the key protective factor in developing fall prevention programs among post-stroke people. People with low fall efficacy tend to display fear-related avoidance of activities and become more sedentary, with low activity participation. It is also proved that among stroke people in the sub-acute and chronic stage of recovery, a positive fall history is associated with less fall efficacy. Conversely, individuals with high fall efficacy are more likely to engage in physical activity, which can improve balance, strength, and mobility, thereby reducing the risk of falls. Therefore, it is necessary to improve patients' fall efficacy in developing fall prevention programs. Short Falls Efficacy Scale - International(FES-I) will be used to test patient's fall efficacy.
Balance ability	Balance ability will be measured before the fall prevention program and after patients are discharged in 8 weeks.	Balance ability is the ability to maintain the body's stability, including keeping a certain posture or balance when subjected to external forces. It is one of the important physiological functions of the human body. Balance impairment increases the risk of falling, which leads to balance impairment playing a major role in the usually multi-factorial etiology of falls. In addition, it is proved that balance ability is a strong predictor of falls in post-stroke people. Therefore, balance ability will be the primary outcome of the fall prevention program. Berg Balance Scale (BBS) will be used to assess the balance ability in post-stroke people.

Secondary Outcome Measures

Name	Time	Method
Number of falls	Number of falls will be measured after patients are discharged in 8 weeks